Skip to main content
Clinical Trials/NCT03964948
NCT03964948
Completed
N/A

Development of Novel MRI Methods for Detecting and Measuring Renal Injury/Fibrosis

Children's Hospital Medical Center, Cincinnati1 site in 1 country37 target enrollmentAugust 6, 2018
ConditionsKidney Diseases

Overview

Phase
N/A
Intervention
Not specified
Conditions
Kidney Diseases
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
37
Locations
1
Primary Endpoint
Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.

Registry
clinicaltrials.gov
Start Date
August 6, 2018
End Date
June 18, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects who meet all of the following criteria will be eligible for the study:
  • ≥ 10 and ≤ 25 years of age and;
  • Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
  • Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
  • Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
  • Healthy Controls

Exclusion Criteria

  • Subjects who meet any of the following criteria will be excluded from the study:
  • Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
  • Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
  • Inability to undergo MRI without sedation/anesthesia.
  • Non-English Speaking

Outcomes

Primary Outcomes

Development of noninvasive MRI methods to measure kidney disease using T1rho mapping.

Time Frame: 3 years

Development of noninvasive MRI methods to measure kidney disease using T2 mapping.

Time Frame: 3 years

Development of noninvasive MRI methods to measure kidney disease using magnetization transfer imaging.

Time Frame: 3 years

Development of noninvasive MRI methods to measure kidney disease using MR elastography.

Time Frame: 3 years

Development of noninvasive MRI methods to measure kidney disease using quantitative T1 mapping.

Time Frame: 3 years

Development of noninvasive MRI methods to measure kidney disease using diffusion-weighted imaging.

Time Frame: 3 years

Intra-voxel incoherent motion and diffusion tensor imagining will be measured.

Study Sites (1)

Loading locations...

Similar Trials